Novartis weighs in to CDF de-listing debate

Novartis has revealed it is also among pharma companies whose drugs face de-listing from the UK Cancer Drugs Fund (CDF), and has issued a stinging rebuke of the way the issue is being handled.

The Swiss company has confirmed its Afinitor (everolimus) product for breast, pancreatic and kidney cancer will be removed from the CDF list when NHS England announces the drugs it will no longer support next week.

In a statement, Novartis has criticised the methodology used in the de-listing process as ‘insufficiently robust and transparent’, taking particular exception to the ‘crude cost element which does not reflect the true value of cancer drugs’.

The company wants NHS England – which administers the CDF – to ‘stop the process now and enter into constructive dialogue with all stakeholders to find an equitable solution’, along with reform of the National Institute for Health and Care Excellence (NICE) review process to allow more cancer drugs to be approved for use by the NHS and so alleviate pressure on the CDF.

Novartis goes on to claim that the process ‘breaches fundamental principles of transparency and undermines the Pharmaceutical Price Regulation Scheme [PPRS] that was introduced with the express intention to increase patient access to innovative medicines’.

Afinitor will no longer be available through the CDF as of 12th March, although patients already allocated funding for the treatment will be unaffected by the de-listing.

Sanofi and Celgene have also revealed that some of their products would be de-listed from the £280m fund – which has supported the cost of treatment for around 55,000 people but looks set to go over budget by around £100 million by the end of the financial year.

Others reported to be in frame for removal from the CDF include Roche’s Avastin (bevacizumab), Kadcyla (trastuzumab emtansine) and Perjeta (pertuzumab) as well as GlaxoSmithKline’s Tyverb (lapatinib).

Blood cancers in the firing line

The list of 24 drugs in 42 separate indications evaluated at the last CDF panel meeting on 15th-16th December, which includes those under threat of de-listing, is particularly heavy on therapies for haematological malignancies such as leukaemias, lymphomas and myeloma, which account for around 40 per cent of the cases under review.

Medical charity Leukaemia & Lymphoma Research says it is deeply concerned by the high number of blood cancer drugs up for review, particularly as the list mainly contains drugs that provide a significant clinical benefit and make a real difference to patients and their families.

Professor Chris Bunce, research director at Leukaemia & Lymphoma Research, said: “Several drugs for blood cancer patients in England are currently only available through the Cancer Drug Fund.

“We know these drugs are clinically effective. For some of these drugs, they represent the only treatment available for that patient population. In other cases, patient populations for the drug indication are very small, so the total cost burden to the NHS is low. We are very concerned at the possibility of any of these drugs being withdrawn.

“The Cancer Drugs Fund is only a temporary measure in place until 2016. A constructive dialogue between all parties is required to get to a long-term and sustainable system that ensures patients can access the treatments they need.”

That view was echoed by Eric Lowe, chief executive of Myeloma UK, who told the BBC that in their opinion the CDF was unsustainable and a ‘public anomaly’, questioning why the major political parties remained committed to the concept.

He said the pharma industry had “behaved badly” with regard to the pricing of new cancer drugs, and said Myeloma UK supported the CDF’s efforts to reduce costs.